The Cosmetic Act B.E. 2535 (1992) was the overarching cosmetic regulation in Thailand and remained unchanged for more than 20 years. As a member of ASEAN, Thailand was required to be adopted and implemented ASEAN Cosmetic Directive (ACD) in 2008. However, the Cosmetic Act B.E. 2535 did not fully align with the ACD. To change the status, an amended Act named Cosmetic Act B.E. 2558 (2015) implemented on September 9 2015. Since then, an improved notification system was established and the notification is valid for only 3 years instead of life-time which will indirectly promote the development of cosmetic industry. The post-market surveillance becomes the emphasis to cosmetic supervision.
Part 1 Regulatory Framework and Competent Authority
1 Existing Main Cosmetic Regulations in Thailand
|Regulations of Notification Receipt||2018-08-23||In force|
|Criteria, Procedures and Conditions for Production or Import of Cosmetic Products||2018-05-04||In force|
|Requirements for Application of Accreditation and Certification of Manufacture and Import Sites||2018-05-17||In force|
|Criteria, Procedures and Conditions for Manufacturers for Sale, Importers for Sale or Manufacture Contractor to Keep Cosmetic Information for Examination||2018-04-12||In force|
|Requirements for Cosmetic Labeling||2019-06-15||In force|
2 Competent Authority of Cosmetics
The Minister of Public Health is in charge of formulating and issuing cosmetic regulations, measures and standards and the execution of the regulations.
The Food and Drug Administration focuses on the notification and post-market surveillance of cosmetics.
The Cosmetics Committee is responsible for
giving advice and consultation to the Minister on matters relating to policies and regulatory measures for cosmetics under the Cosmetic Act B.E. 2558;
giving advice and consultation to the Minister on the issuing of announcements;
giving advice and consultation on the revocation of notification receipts;
approving the revocation of notification receipts;
performing other functions as may be prescribed by law or as assigned by the Minister.
Part 2 Cosmetic Products
Cosmetic product refer to any substance or preparation intended to be placed in contact (by applying to, massaging or rubbing into, sprinkling or spraying on, dropping onto, introducing into, perfuming, or by any other means,) with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition but shall not include ornaments and clothing which are deemed as accessories outside human body.
Any products having pharmaceutical characteristics such as those affecting or altering the functions or structure of human body or presenting as pharmaceutical products are outside the scope of cosmetic regulation. List of Names of Cosmetics Prohibited for Manufacture, Import and Sale and Cosmetics Prohibited for Manufacture, Import and Sale defines certain cosmetics prohibited for manufacture, import and sale.
2 Manufacture and Import Requirements
Manufacturers and importers are required to comply with the Criteria, Procedures and Conditions for Production or Import of Cosmetic Products. The regulation is designated to help the manufacturers and importers to improve or develop their practices in manufacturing or importing cosmetic products. The guidelines cover various topics, namely definitions, personnel, premises, sanitation and hygiene, equipment, production operations, import methods, and import qualifications, etc. Manufacturers/importers need to apply for a certificate of the manufacturing/importing site, which is required for application of notification receipts. After receiving the application, the authority will conduct an inspection to confirm the compliance and issue the certificate for compliant manufacturers/importers.
Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics. A person who manufactures or imports cosmetic samples for the purpose of an exhibit or promotional display or for purpose of study, research or laboratory analysis shall be exempt from the requirement to obtain a notification receipt.
The steps for notification are as follows.
1. Notify the information of cosmetic products to the authority prior to producing or importing. Once the information is completed and correct, the applicant will received the notification receipt which is valid for 3 years.
2. Manufacture or import the cosmetic product according to the notification.
3. Prepare label. Information must be written in Thai language and must be the size that is easily legible. The contents must be the accurate and must not be misleading. References should be documented for inspection.
4. Advertise the cosmetic product based on its fact without misleading contents. References should be documented for inspection.
Details for notification include:
|1||Information of the applicant|
|2||Information of the cosmetic product|
|3||A notifying form|
|4||Disclaimer of application|
Note: If the manufacturing or storage sites are located in Bangkok, the manufacturers or the importers must notify at the Food and Drug Administration office. If the manufacturing or storage sites are located in other provinces, the manufacturers or the importers must notify at the provincial public health office where the sites are located. The manufacturers or the importers may also notify the information via the computer network of the Food and Drug Administration.
The notification receipt shall remain valid for a period of three years as from the date of issue. Should the applicant wish to renew the notification receipt, he/she shall submit a renewal request prior to the expiration date. A change of the information in the notification receipt is also allowed.
4 Labeling Requirements
All cosmetic products must have Thai legal labeling within 30 days after importation date before putting in market. Labels must bear the following information:
Product name and trade name: (Font size must be bigger than other content)
Type: (i.e. shampoo, conditioner, whitening skin care, etc)
Full ingredient list (FIL)
Direction for use
Manufacturer name + country or Importer name + address
Net content in metric (ml or gram): (Font size 2mm.(<50)3mm(50-200)4 mm.(200-1000) 5mm (1000 up)
Expiry date (for products with shelf-life less than 30 months)
Warning (in accordance with MOPH notification)
Notification receipt number
All the information contained on the label must be accurate and must not contain any information which could result in a serious misunderstanding; all information must be ethical and in keeping with Thai cultural norms. Information must be written in the Thai language and must be of a size that is easily legible; information may also be provided in a foreign language. Cosmetics imported for sale in the Kingdom are not required to have a Thai-language label on the packaging or wrapping at the time of customs inspection but a Thai-language label must be affixed prior to sale.
The labels of cosmetic products may present the claims of use within the scope of cosmetics similar to those claims presented in advertising. The manufacturers or importers must retain the profile of product information including the evidence supporting those claims. Claims must not indicate that the products have any pharmaceutical characteristics or capability to affect or alter human body’s functions or structure. Additionally, these claims must not indicate that those cosmetic products have the capability which, in fact, does not exist (overclaim) or is the cause of misunderstanding in their quality (misleading).
Cosmetics advertising must not contain statements intended to deceive consumers or that may have negative effects on society at large. This includes all statements regarding a product’s place of origin, condition, quality, quantity or properties;
Statements of the following types are considered as intended to deceive consumers or as having possible negative effects on the society at large:
(1) statements that are false or overstate the truth;
(2) statements that cause serious misunderstanding of the product either through the mention of scientific data, statistics, or anything else that is not true or that overstates the truth;
(3) statements that make medical claims or whose purpose is other than cosmetic;
(4) statements that lead consumers to believe that the product may enhance libido or sexual performance;
(5) statements that either directly or indirectly promote the commission of a crime
or immoral act, or that have a degrading effect on the nation’s morals;
(6) statements that may cause dissension or disunity among the public;
(7) any other statements as stipulated by Ministerial rules)
The statement used for the advertisement of the cosmetics and known to the public that is utterly unrealistic shall not be deemed as the prohibited statement in the advertisement of the cosmetics stated in the second paragraph (1).
The advertisement of the cosmetics shall not be conducted in any certain manner that causes trouble to consumers or deemed harmful to consumers’ health, mentality and morality.
6 Post-market Surveillance
Thai FDA conducts five areas of post-market surveillance, namely inspection, market surveillance, advertisement investigation, adverse product reaction surveillance, and the improvement of manufacture.
Inspections will be performed periodically throughout the year. The activities, including inspection and product sampling, will be carried out in accordance with the annual plan and in response to the complaints or reports of adverse reactions or surveillance. The collected products will be tested for fraudulent characteristics. Any products found to be harmful to human health will be recalled or confiscated under the authority of FDA, and will eventually be destroyed in order to ensure that such products will not be re-marketed.
Information required for possible inspections are as follows:
|Data of ready-made cosmetics|
Market surveillance is performed all year round and includes the investigation of product labeling and the collection of marketed product samples at the inspected place. All claims imprinted on the labels of cosmetic products must have the supporting evidence kept in a ready-to-be-delivered manner.
Advertisements of cosmetics must indicate the products’ benefits pertaining to cosmetic scope and purposes. Cosmetic claims are forbidden from indicating that the products have any pharmaceutical characteristics or capability to affect or alter human body’s functions or structure; otherwise such products will be regarded as drugs and thus manipulated under the Drug Act instead. Additionally, all advertisements must neither claim nor indicate that those cosmetic products have the capability which, in fact, does not exist or is the cause of misunderstanding in their quality. The cosmetic products with fraudulent claims in labeling or advertising will be recalled and followed by inspections.
The manufacturers and the Thai (FDA) use these guidelines for their operations and inspection to ensure the standard of products manufactured. Manufacturers/Importers must prepare Product Information File (PIF) ready to be inspected by TFDA.
Part 3 Ingredients
Ingredients are the key to cosmetic safety control. Hence, ingredients are revised, studied and considered before being approved by the Cosmetic Committee. There are five listings of cosmetic ingredients designated, namely prohibited substances, restricted substances, preservatives, colorants and sunscreens.